Details for New Drug Application (NDA): 203385
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The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
Summary for 203385
Tradename: | DACTINOMYCIN |
Applicant: | Eugia Pharma |
Ingredient: | dactinomycin |
Patents: | 0 |
Pharmacology for NDA: 203385
Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 203385
Suppliers and Packaging for NDA: 203385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-431 | 55150-431-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-928 | 55150-928-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL | ||||
Approval Date: | Nov 9, 2017 | TE: | AP | RLD: | No |
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